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# FDA Complete Response Letter for Zetia/Vytorin sNDAs
- URL: https://www.fdaweb.com/fda-complete-response-letter-for-zetia-vytorin-sndas/
- Published: 2016-02-16T12:00:00.000Z
- Updated: 2026-09-15T02:36:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134766

> FDA has issued a complete response letter for a Merck sNDAs for Zetia and Vytorin to reduce the risk of cardiovascular events in patients with coronary heart disease. The company says the applications were based on results of IMPROVE-IT (Improved Reduction of Outcomes Vytorin Efficacy International Trial). It says it is reviewing the letter, whose contents were not disclosed, and will determine next steps.  
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> The two drugs are indicated for use with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia.